Multiple Sclerosis Clinical Trial

Functional Outcomes From Diets in Multiple Sclerosis

Summary

The purpose of this study is to test the effects of two dietary interventions, glycemic load and calorie restriction, on physical function, cognition, pain, fatigue, mood, and anxiety in adults with multiple sclerosis (MS). The investigators will also explore the how the diet interventions impact inflammation, immunity, and metabolic biomarkers.

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Full Description

100 participants will be randomized 1:1 to follow either a low glycemic load (GL) or standard GL diet for 32 weeks. For the first 16 weeks, all participants will eat enough calories to maintain their baseline weight. During the second 16 weeks, all participants will reduce calorie intake by 500kcal/day, with a goal of losing 5-10% of initial body weight. Participants will complete data collection at baseline (prior to randomization), at 17 weeks (after the weight stable phase) and again after completing the calorie restriction phase.

All participants will receive meal plans and groceries for the duration of the trial.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Diagnosed with RRMS or SPMS
BMI 25-50 kg/m2 (overweight/obese)
EDSS ≤6.5 (able to walk 100m with or without assistance)
If on disease-modifying treatment (DMT), stable for 6 months
If not on DMT, no DMT in previous 6 months
No expected change to DMT in next 34 weeks
Responsible for food preparation or have input into food preparation

Exclusion Criteria:

MS relapse in previous 30 days
Unable to walk 25 feet with or without assistive device
Pregnant or breastfeeding
Current use of insulin or sulfonylurea agents
Score indicating low cognitive functioning on the Telephone Interview for Cognitive Status (TICS-m) assessment
Actively engaged in a weight loss program or unwilling to follow assigned dietary pattern
Unable to receive, store, or prepare food according to diet plan
Medical contraindication to either treatment or control diet (including severe allergies that cannot be accommodated within either group)

Study is for people with:

Multiple Sclerosis

Estimated Enrollment:

100

Study ID:

NCT05327322

Recruitment Status:

Recruiting

Sponsor:

University of Alabama at Birmingham

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There are 2 Locations for this study

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University of Alabama at Birmingham
Birmingham Alabama, 35294, United States More Info
Brooks C Wingo, PhD
Contact
205-934-5982
[email protected]
Kathryn Green, BS
Contact
[email protected]
Washington University
Saint Louis Missouri, 63110, United States More Info
Laura Piccio, MD, PhD
Contact
[email protected]
Courtney Dula
Contact
[email protected]

How clear is this clinincal trial information?

Study is for people with:

Multiple Sclerosis

Estimated Enrollment:

100

Study ID:

NCT05327322

Recruitment Status:

Recruiting

Sponsor:


University of Alabama at Birmingham

How clear is this clinincal trial information?

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